Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT05852769
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2023-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}, {'id': 'C093875', 'term': 'montelukast'}, {'id': 'D005480', 'term': 'Flurbiprofen'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D004077', 'term': 'Digoxin'}, {'id': 'D017035', 'term': 'Pravastatin'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 26 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])', 'timeFrame': 'Up to 26 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])', 'timeFrame': 'Up to 26 days'}], 'secondaryOutcomes': [{'measure': 'Time of maximum observed serum concentration (Tmax)', 'timeFrame': 'Up to 26 days'}, {'measure': 'Apparent terminal phase half-life (T-Half)', 'timeFrame': 'Up to 26 days'}, {'measure': 'Apparent total body clearance (CLT/F)', 'timeFrame': 'Up to 26 days'}, {'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 52 days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 21 days'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 28 days'}, {'measure': 'Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score', 'timeFrame': 'Up to 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986196'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSStudyConnect.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.\n* Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m\\^2), inclusive, and body weight ≥50.0 kg.\n\nExclusion Criteria:\n\n* History of rhabdomyolysis.\n* History of peptic ulcer disease or significant GI bleeding.\n* History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).'}, 'identificationModule': {'nctId': 'NCT05852769', 'briefTitle': 'A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM038-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986196 and/or Cocktail Probe Substrate Drugs', 'interventionNames': ['Drug: BMS-986196', 'Drug: Caffeine', 'Drug: Montelukast', 'Drug: Flurbiprofen', 'Drug: Omeprazole', 'Drug: Midazolam', 'Drug: Digoxin', 'Drug: Pravastatin']}], 'interventions': [{'name': 'BMS-986196', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986196 and/or Cocktail Probe Substrate Drugs']}, {'name': 'Caffeine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986196 and/or Cocktail Probe Substrate Drugs']}, {'name': 'Montelukast', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986196 and/or Cocktail Probe Substrate Drugs']}, {'name': 'Flurbiprofen', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986196 and/or Cocktail Probe Substrate Drugs']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986196 and/or Cocktail Probe Substrate Drugs']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986196 and/or Cocktail Probe Substrate Drugs']}, {'name': 'Digoxin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986196 and/or Cocktail Probe Substrate Drugs']}, {'name': 'Pravastatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986196 and/or Cocktail Probe Substrate Drugs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Millcreek', 'state': 'Utah', 'country': 'United States', 'facility': 'ICON plc', 'geoPoint': {'lat': 40.68689, 'lon': -111.87549}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}